POSITION OVERVIEW:

Syner-G is seeking a Sr. Process Engineer with 7–11 years of experience to lead the design, optimization, and automation of manufacturing and laboratory processes. This role will serve as a primary Subject Matter Expert (SME) for key cell therapy unit operations and will guide process monitoring, improvement initiatives, technical investigations, and technical transfers within cGMP environments. The Senior Process Engineer will provide strategic and hands-on support across process development, operations, quality, and regulatory functions, driving process robustness, efficiency, scalability, and compliance across client programs.

WORK LOCATION:
Travel to client sites may be required up to 100 percent, based on project demands and client expectations.

KEY RESPONSIBILITIES:
(This list is not exhaustive and may be supplemented or changed as necessary.)

• Act as the primary SME for assigned cell therapy unit operations such as cell selection, gene transduction, cell expansion, and cryopreservation within cGMP manufacturing.
• Provide Person-in-Plant (PIP) support during critical operations, ensuring real-time technical guidance and issue resolution.
• Lead complex deviations and investigations to determine root causes and establish corrective and preventative actions (CAPAs).
• Establish and maintain process control strategies for critical process parameters (CPPs) and critical quality attributes (CQAs).
• Conduct data trending, process performance assessments, and modeling to identify improvement opportunities.
• Propose and execute technical projects to optimize yields, reduce cycle times, and enhance process robustness and scalability.
• Lead the development, optimization, and scale-up of manufacturing and laboratory processes across upstream, downstream, or formulation operations.
• Oversee process automation initiatives, including equipment integration and implementation of advanced control strategies.
• Lead commissioning, qualification, and startup of process equipment and automated systems.
• Partner with automation, engineering, and operations teams to implement digital tools, process monitoring systems, and data-driven frameworks.
• Troubleshoot high-impact equipment, process, and automation issues, providing technical direction to junior staff.
• Lead technical transfer of manufacturing processes between development and manufacturing groups or across internal and external sites.
• Ensure process consistency, scalability, and alignment with quality system expectations during transfer.
• Author, review, and approve technical protocols, reports, memos, SOPs, and change control documentation.
• Provide technical data and narrative content for regulatory submissions including IND amendments and CTA filings.
• Support the evaluation, integration, and validation of new technologies or systems to ensure scalability, reliability, and operational readiness.
• Work closely with Quality Assurance, Manufacturing Operations, Development, and Regulatory Affairs to align on technical strategies and execution plans.
• Manage vendor relationships, equipment upgrades, and external technical partnerships.
• Mentor and support junior engineers, providing technical coaching and oversight.

QUALIFICATIONS AND REQUIREMENTS:

Education

• BS or MS in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or a related technical field preferred.

Experience

• 7–11 years of process engineering experience within biotech, pharmaceutical, or advanced manufacturing environments.
• Extensive hands-on experience with automated process equipment such as bioreactors, chromatography systems, filtration skids, or formulation systems.
• Strong familiarity with process automation platforms such as DeltaV, Rockwell, Siemens, or SCADA and PLC systems.
• Proven experience leading process development, scale-up, equipment integration, and optimization initiatives.
• Demonstrated ability to lead cross-functional teams and mentor junior staff.

Technical Skills

• Strong understanding of process engineering fundamentals, mass and energy balances, process control principles, and equipment design.
• Ability to interpret and develop P&IDs, engineering drawings, and automation logic.
• Advanced data analysis skills, including statistical methods, modeling tools, and engineering software.
• Strong communication, leadership, and project management abilities.
• Ability to manage multiple complex priorities in fast-paced environments.

ESSENTIAL FUNCTIONS:

Physical Demands:
Regular use of a computer, keyboard, and mouse; reaching with hands and arms; talking and listening. Frequent walking and sitting; occasional standing, stooping, or kneeling. Must be able to lift and carry objects up to 25 pounds. Requires close vision and ability to adjust focus.

Work Environment:
Indoor office environment with moderate noise, bright lighting, and typical office conditions.

 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

COMPENSATION:
The expected salary range for this position is $125,000 to $188000 yearly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.